Rectal spacer hydrogel in 1.5T MR-guided and daily adapted SBRT for prostate cancer: dosimetric analysis and preliminary patient-reported outcomes

Alongi, Filippo; Rigo, Michele; Figlia, Vanessa; Cuccia, Francesco; Giaj-Levra, Niccolò; Nicosia, Luca; Ricchetti, F.; Vitale, Claudio; Sicignano, G.; Simone, Antonio De; Naccarato, S.; Ruggieri, R.; Mazzola, Rosario

doi:10.1259/bjr.20200848

Cited by 29 publications

(27 citation statements)

References 19 publications

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“…Interestingly, the authors recorded a significant advantage in terms of rectal sparing and target coverage, in comparison with a cohort of patients who did not receive the administration of the rectal spacer. In addition, despite the invasive procedure, no adverse impact on QoL was observed using PROMs assessment [43].…”

Section: Mr-guided Radiotherapy: Present Evidencementioning

confidence: 89%

MR-Guided Hypofractionated Radiotherapy: Current Emerging Data and Promising Perspectives for Localized Prostate Cancer

Cuccia

Corradini

Mazzola

et al. 2021

Cancers

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In this review we summarize the currently available evidence about the role of hybrid machines for MR-guided radiotherapy for prostate stereotactic body radiotherapy. Given the novelty of this technology, to date few data are accessible, but they all report very promising results in terms of tolerability and preliminary clinical outcomes. Most of the studies highlight the favorable impact of on-board magnetic resonance imaging as a means to improve target and organs at risk identification with a consequent advantage in terms of dosimetric results, which is expected to relate to a more favorable toxicity pattern. Still, the longer treatment time per session may potentially affect the patient’s compliance to the treatment, although first quality of life assessment studies have reported substantial tolerability and no major impact on quality of life. Finally, in this review we hypothesize some future scenarios of further investigation, based on the possibility to explore the superior anatomy visualization and the role of daily adapted treatments provided by hybrid MR-Linacs.

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Section: Mr-guided Radiotherapy: Present Evidencementioning

confidence: 89%

MR-Guided Hypofractionated Radiotherapy: Current Emerging Data and Promising Perspectives for Localized Prostate Cancer

Cuccia

Corradini

Mazzola

et al. 2021

Cancers

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“…They did not compare with and without a hydrogel spacer, so the efficacy of the hydrogel spacer in SBRT was not shown in that study. A recently published study evaluated clinician-reported outcomes and PROs between the spacer and no-spacer patients as a subgroup analysis of the ongoing prospective observational study [ 26 ]. The results showed no difference between the pre- and post-SBRT in spacer and no-spacer groups, but the number of patients (10 patients in each group) may be too small to see a statistical difference.…”

Section: Discussionmentioning

confidence: 99%

Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

et al. 2021

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Background The efficacy of a hydrogel spacer in stereotactic body radiotherapy (SBRT) has not been clarified. We evaluated the safety and efficacy of SBRT in combination with a hydrogel spacer for prostate cancer. Methods This is a prospective single-center, single-arm phase II study. Prostate cancer patients without lymph node or distant metastasis were eligible. All patients received a hydrogel spacer insertion, followed by SBRT of 36.25 Gy in 5 fractions with volumetric modulated arc therapy. The primary endpoint was physician-assessed acute gastrointestinal (GI) toxicity within 3 months. The secondary endpoints were physician-assessed acute genitourinary (GU) toxicity, patient-reported outcomes evaluated by the EPIC and FACT-P questionnaires, and dosimetric comparison. We used propensity score-matched analyses to compare patients with the hydrogel spacer with those without the spacer. The historical data of the control without a hydrogel spacer was obtained from our hospital’s electronic records. Results Forty patients were enrolled between February 2017 and July 2018. A hydrogel spacer significantly reduced the dose to the rectum. Grade 2 acute GI and GU toxicity occurred in seven (18%) and 17 (44%) patients. The EPIC bowel and urinary summary score declined from the baseline to the first month (P < 0.01, < 0.01), yet it was still significantly lower in the third month (P < 0.01, P = 0.04). For propensity score-matched analyses, no significant differences in acute GI and GU toxicity were observed between the two groups. The EPIC bowel summary score was significantly better in the spacer group at 1 month (82.2 in the spacer group and 68.5 in the control group). Conclusions SBRT with a hydrogel spacer had the dosimetric benefits of reducing the rectal doses. The use of the hydrogel spacer did not reduce physician-assessed acute toxicity, but it improved patient-reported acute bowel toxicity. Trial registration: Trial registration: UMIN-CTR, UMIN000026213. Registered 19 February 2017, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029385.

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“…This is also con rmed by our previous studies that report excellent results in terms of PROMs evaluation, regardless of the potential detrimental effect of longer treatment sessions on patient's compliance. [28][29][30] The higher accuracy of this work ow certainly increases clinicians' con dence in proposing doseescalated or single-session schedules. [31,32] Based on this background, we hypothesized to investigate a dose escalated SBRT schedule which is currently ongoing at our department, aiming also to reduce the sessions, in agreement with the growing literature in support of the single-fraction treatment of oligometastases.…”

Section: Discussionmentioning

confidence: 99%

Mitigation on bowel loops daily variations by 1.5-T MR-guided daily-adaptive SBRT for abdomino-pelvic lymph-nodal oligometastases

Cuccia

Rigo

Gurrera

et al. 2021

J Cancer Res Clin Oncol

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We report preliminary dosimetric data concerning the use of 1.5-T MR-guided daily-adaptive radiotherapy for abdomino-pelvic lymph-nodal oligometastases. We aimed to assess the impact of this technology on mitigating daily variations for both target coverage and organs-at-risk (OARs) sparing. MethodsA total of 150 sessions for 30 oligometastases in 23 patients were analyzed. All patients were treated with MR-guided stereotactic body radiotherapy (SBRT) for a total dose of 35Gy in 5 fractions. For each fraction, a quantitative analysis was performed for PTV volume, V35Gy and Dmean. Similarly, for OARs we assessed daily variations of volume, Dmean, Dmax. Any potential statistically signi cant change between baseline planning and daily-adaptive sessions was assessed using the Wilcoxon signed-rank test, assuming a p-value< 0.05 as signi cant. ResultsAverage baseline PTV, bowel, bladder and single intestinal loop volumes were respectively 8.9cc (range, 0.7-41.2cc), 1176cc (119-3654 cc), 95cc (39.7-202.9 cc), 18.3cc (9.1-37.7 cc). No signi cant volume variations were detected for PTV (p=0.21) bowel (p=0.36), bladder (p=0.47), except for single intestinal loops, which resulted smaller (p=0.026).Average baseline V35Gy and Dmean for PTV were respectively 85.6% (72-98.8%) and 35.6 Gy (34.6-36.1 Gy). We recorded a slightly positive trend in favor of daily-adaptive strategy vs baseline planning for improved target coverage, although not reaching statistical signi cance. (p=0.11 and p=0.18 for PTV-V35Gy and PTV-Dmean).Concerning OARs, a signi cant difference was observed in favor of daily-adapted treatments in terms of single intestinal loop Dmax [23.05 Gy (13.2-26.9 Gy) at baseline vs 20.5 Gy (12.1-24 Gy); p-value=0.0377] and Dmean [14.4 Gy (6.5-18 Gy) at baseline vs 13.0 Gy (6.7-17.6 Gy); p-value=0.0003].Speci cally for bladder, the average Dmax was 18.6 Gy (0.4-34.3 Gy) at baseline vs 18.3 Gy (0.7-34.3 Gy) for a p-value=0.28; the average Dmean was 7.0 Gy (0.2-16.6 Gy) at baseline vs 6.98 Gy (0.2-16.4 Gy) for a p-value=0.66. Concerning the bowel, no differences in terms of Gy) vs 5.6 Gy (1.4-10.5 Gy); p-value=0.23] were observed between after daily-adapted sessions. A statistically signi cant difference was observed for bowel Dmax [26.4 Gy (7.7-34 Gy) vs 25.8 Gy (7.8-33.1 Gy); p-value=0.0086]. ConclusionsDaily-adaptive MR-guided SBRT reported a signi cantly improved single intestinal loop sparing for lymphnodal oligometastases. Also bowel Dmax was signi cantly reduced with daily-adaptive strategy. A minor

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Rectal spacer hydrogel in 1.5T MR-guided and daily adapted SBRT for prostate cancer: dosimetric analysis and preliminary patient-reported outcomes

Cited by 29 publications

References 19 publications

MR-Guided Hypofractionated Radiotherapy: Current Emerging Data and Promising Perspectives for Localized Prostate Cancer

MR-Guided Hypofractionated Radiotherapy: Current Emerging Data and Promising Perspectives for Localized Prostate Cancer

Phase II study of stereotactic body radiotherapy with hydrogel spacer for prostate cancer: acute toxicity and propensity score-matched comparison

Mitigation on bowel loops daily variations by 1.5-T MR-guided daily-adaptive SBRT for abdomino-pelvic lymph-nodal oligometastases

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